Wed.May 31, 2023

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Biohaven sends latest drug to FDA, despite past trial setback

Bio Pharma Dive

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

Trials 317
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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

Drugs 278
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FDA pauses PepGen’s plans to test muscle disease drug

Bio Pharma Dive

The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.

Drugs 258
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Stealth and Pharmanovia partner for commercialisation of elamipretide

Pharmaceutical Technology

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.

Licensing 245
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer’s RSV vaccine wins FDA approval in older adults

Bio Pharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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University of Sydney will use AI to boost cancer drug research

Pharmaceutical Technology

The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.

Research 147

More Trending

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ZNA-1041 by F. Hoffmann-La Roche for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

In-Vitro 130
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May 31, 2023: PROACT Xa Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w

Trials 130
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BBT-401 by Bridge Biotherapeutics for Ulcerative Colitis: Likelihood of Approval

Pharmaceutical Technology

BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BBT-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Meeting Global Demands for Viral Vector-based Vaccines

Pharma Mirror

In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Anocca raises over $36 million for cancer cell therapy studies

Pharmaceutical Technology

Anocca has raised SEK 400 million ($36.7 million) in an equity financing round that will be used to move the company’s cell therapy candidates into the clinic in 2024, based on a 31 May press release. The funding will also be used to work on Anocca’s cell therapy discovery and manufacturing process. The round was led by the Swedish pension fund AMF and the investment firm Mellby Gård.

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May 31, 2023: NIH Pragmatic Trials Collaboratory Announces Virtual Workshop on Getting the Right Evidence to Decision-Makers Faster

Rethinking Clinical Trials

Save the date! The NIH Pragmatic Trials Collaboratory will host a virtual workshop June 20-21, 2023, to explore the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems. The workshop, Getting the Right Evidence to Decision-Makers Faster , will kick off on Tuesday, June 20, at 11:00 a.m.

Trials 100
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FDA accepts Bristol Myers Squibb’s repotrectinib NDA for review

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Its favourable properties for penetrating the human brain increase intracranial activity.

Trials 130
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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer

Fierce Pharma

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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GRANITE-001 by Gritstone Bio for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

GRANITE-001 is under clinical development by Gritstone Bio and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction. According to GlobalData, Phase II drugs for Adenocarcinoma Of The Gastroesophageal Junction have a 51% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how GRANITE-001’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Lowering Sodium Levels: A New Perspective for Cognitive Health

XTalks

Warnings against high sodium intake, particularly table salt, have been consistently issued by the World Health Organization (WHO) and numerous health-promoting organizations. Now, there’s a fresh perspective from a new study that highlights not only the effects of high sodium on hypertension, but also its correlation with emotional and cognitive impairment.

Protein 111
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ATRN-119 by Aprea Therapeutics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ATRN-119’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Sym-021 by Les Laboratoires Servier for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Former Novartis execs cleared of Greek bribery charges after yearslong investigation

Fierce Pharma

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.

Doctors 106
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Setanaxib by Calliditas Therapeutics for Primary Biliary Cholangitis (Primary Biliary Cirrhosis): Likelihood of Approval

Pharmaceutical Technology

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

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Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at …

ProRelix Research

Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared first on ProRelix Research.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Fruquintinib by Takeda Pharmaceutical for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval

Pharmaceutical Technology

Fruquintinib is under clinical development by Takeda Pharmaceutical and currently in Phase II for Triple-Negative Breast Cancer (TNBC). According to GlobalData, Phase II drugs for Triple-Negative Breast Cancer (TNBC) have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Fruquintinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Drugs 100
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Biotech IPOs in 2023: Shaping the Future of Innovation

XTalks

An initial public offering (IPO) is the process through which a privately held company offers its shares to the public for the first time, transforming into a publicly traded company. In the biotech industry, a biotech IPO refers to a specific case where a biotechnology company goes public and lists its shares on a stock exchange. This allows the company to raise funds from public investors.

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Amgen’s Otezla shows promise in psoriatic arthritis

Pharma Times

The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide

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Algiax Pharmaceuticals 'convinced' they can provide new treatment for chronic pain relief

Outsourcing Pharma

A small molecule drug candidate from Algiax Pharmaceuticals can reduce excitability of neurons in relation to chronic pain, dampening signal and reducing pain, a study shows.

Drugs 84
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research

pharmaphorum

ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research Mike.

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US appeal in high-stakes Gilead patent case garners support from patient advocates

Fierce Pharma

Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. | Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal.

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PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one

pharmaphorum

PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one Mike.

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Sanofi announces positive data for frexalimab in relapsing MS

Pharma Times

The neurological disease affects approximately 2.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.